FDA 510(k)

Luna 3D GEN2 Interbody Fusion System

K-Number: K183560 · 2019-05-23

Decision Date2019-05-23

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Luna 3D GEN2 Interbody Fusion System is a medical device manufactured by Benvenue Medical, Inc.. It received FDA 510(k) clearance on 2019-05-23 under approval number K183560. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luna 3D GEN2 Interbody Fusion System?

Luna 3D GEN2 Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by Benvenue Medical, Inc.. The 510(k) number is K183560.

When was Luna 3D GEN2 Interbody Fusion System approved by the FDA?

Luna 3D GEN2 Interbody Fusion System received FDA 510(k) clearance on 2019-05-23, under approval number K183560.

What company makes Luna 3D GEN2 Interbody Fusion System?

Luna 3D GEN2 Interbody Fusion System is manufactured by Benvenue Medical, Inc..

What is the FDA product code for Luna 3D GEN2 Interbody Fusion System?

The FDA product code for Luna 3D GEN2 Interbody Fusion System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Benvenue Medical, Inc.

K162431Luna 3D Interbody Fusion System K201427Trivergent Spinal Fixation System K193172Luna XD Ti Interbody Fusion System

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.